Dr Reddy's Laboratories (UK) Ltd & Anor v Warner-Lambert Company LLC
The extension of the SPC for atorvastatin was validly granted because the PIP was lawfully approved, the requirements of Article 36 were satisfied, Article 45(3) did not apply, and any technical breach did not warrant revocation of the extension under the court's discretionary power.
- Parties
- Claimant: Dr Reddy’s Laboratories (UK) Ltd; Claimant: Dr Reddy’s Laboratories Ltd; Defendant: Warner-Lambert Company LLC
- Jurisdiction
- England and Wales
- Judgment Date
- 20 December 2012
- Procedural Posture
- Civil / Judgment After Trial
- Outcome
- Claim dismissed
- Legal Topics
- Supplementary Protection Certificate, Paediatric Regulation, Patent Extension, Marketing Authorisation, Judicial Review
Case Brief
Summary, issues, holding and outcome
More case intelligence is available
Unlock the full research layer for this judgment.
Parties
Dr Reddy’s Laboratories (UK) Ltd
Claimant
Dr Reddy’s Laboratories Ltd
Claimant
Warner-Lambert Company LLC
Defendant
Procedural Posture
Civil / Judgment After Trial
Legal Issues
- 1 Whether the extension of the Supplementary Protection Certificate (SPC) for atorvastatin under Article 36 of the Paediatric Regulation was validly granted
- 2 Whether the Paediatric Investigation Plan (PIP) was lawfully approved under the Regulation
- 3 Whether Article 45(3) of the Paediatric Regulation applies to the grant of the paediatric extension
Ratio Decidendi
The extension of the SPC for atorvastatin was validly granted because the PIP was lawfully approved, the requirements of Article 36 were satisfied, Article 45(3) did not apply, and any technical breach did not warrant revocation of the extension under the court's discretionary power.
Court Disposition
Claim dismissed
Full Case Text
Judgment text and source record
Sign in to read
Sign in to read the full judgment text
Sign in to read the full judgment text. Downloads and additional research tools may depend on your plan.
Sign in to read the full judgment